MEDLINE ECVC8040ARecalls & reported problems
Medline Industries, Inc. · VANTEX 7FR 3L 20CM CVC BUNDLE, CHOICE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10653160361589), received between Nov 7, 2023 and Sep 28, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Flush” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Flush1
- Material Integrity Problem1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Difficult to Flush
It was reported that ¿When I initially placed the line the wire went in easily but was bent at an angle when I pulled it out. The line drew normally for the two distal ports but the proximal white port was difficult and I could not pull blood normally, it stopped halfway through and would not draw or flush even when I tried to adjust the line.¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915636 ↗InjuryNov 7, 2023Material Integrity Problem; Material Integrity Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 AFTER INSERTING THE NEEDLE HE WAS "UNABLE TO CREATE NEGATIVE PRESSURE WHILE ATTEMPTING TO ASPIRATE BLOOD".
Patient problems: Needle Stick/Puncture
MAUDE report 18088755 ↗
Other Cardiac catheterization kit devices
- Medline Industries, Inc. DYNJ44700JMedline Industries, Inc. · Cardiac catheterization kit3 recalls1 report
- Medline Industries, Inc. ECVC6845Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. DYNJ33061DMedline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. DYNJ83089Medline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. MNS9935Medline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC5540ACenturion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. DYNJ0578916XMedline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Halyard SAMM066-15_0017Avid Medical, Inc. · Cardiac catheterization kit3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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